Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00539331
First received: October 2, 2007
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: AZD2171
Drug: Paclitaxel
Drug: Carboplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer [ Time Frame: Assessed at each visit during Part A ] [ Designated as safety issue: No ]
  • PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) [ Time Frame: time to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel [ Time Frame: Assessed at each visit during Part A ] [ Designated as safety issue: No ]
  • PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival [ Time Frame: time to death ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Paclitaxel/Carboplatin
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Experimental: 2
Paclitaxel/Carboplatin + AZD2171
Drug: AZD2171
oral tablet
Other Names:
  • cediranib
  • RECENTIN™
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having histologically or cytologically confirmed NSCLC
  • Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
  • WHO performance status 0-1

Exclusion Criteria:

  • Untreated unstable brain or meningeal metastases
  • Patient with inappropriate laboratory tests values
  • Patient with poorly controlled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539331

Locations
Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
Principal Investigator: Masahiro Fukuoka, MD Sakai hospital Kinki University School of Medicine
Study Chair: Xiaojin Shin, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Jane Robertson, MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00539331     History of Changes
Other Study ID Numbers: D8480C00040
Study First Received: October 2, 2007
Last Updated: May 30, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Non-small Cell Lung Cancer
NSCLC
AZD2171
Paclitaxel/Carboplatin
Non-small Cell Lung Cancer (NSCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cediranib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014